MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP ROLLATOR,STEEL,KNOCK-DOWN

Catalog Number MDS86850ESKD

Device Problem Mechanical Problem (1384)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/17/2022

Event Type  Injury  

Manufacturer Narrative

It was reported by the customer that his mother was using the rollator device a few weeks ago to ambulate in the house, fell and injured her left ankle.Per the customer his mother was walking with the rollator to let the dog out' and went to use the brakes but the left side brake would not catch and his mother fell to the floor on her left side.Per the customer she was able to get up on her own but experienced pain post fall.Per the customer his mother went to her primary care physician and was referred to a foot specialist after imaging showed a bone chip and was diagnosed with a sprained ankle.Per the customer his mother has been in a walking boot that was given by the foot specialist since the fall.The customer is reporting that his mother is doing better.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that the customer was using the rollator device and the left side brake would not catch when she went to stop which resulted in a fall.The customer sprained her left ankle.

• Brand Name: ROLLATOR,STEEL,KNOCK-DOWN
• Type of Device: ROLLATOR,STEEL,KNOCK-DOWN
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15136742
• MDR Text Key: 296950624
• Report Number: 1417592-2022-00125
• Device Sequence Number: 1
• Product Code: ITJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MDS86850ESKD
• Device Lot Number: 88521090002
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/08/2022
• Initial Date FDA Received: 07/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 59 KG